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BPV/STN3/0116/0004 BPV/STN3/0116 VENOVO Venous Stent Bard’s Next Generation Venous Stent

VENOVO Venous Stent - linc2016.cncptdlx.com · The VENOVO™ Venous Stent System is indicated for the treatment of stenoses and occlusions in the iliac and femoral veins. Contraindications

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BPV/STN3/0116/0004 BPV/STN3/0116/0004

VENOVO™ Venous Stent

Bard’s Next Generation Venous Stent

BPV/STN3/0116/0004

The speaker’s presentation today is on behalf of Bard Peripheral Vascular, Inc.

Any discussion regarding Bard products during the presentation today is

limited to information that is consistent with the Bard labeling for those

products.

Please consult Bard product labels and inserts for any indications,

contraindications, hazards, warnings, cautions and instructions for use.

The opinions and clinical experiences presented herein are for informational

purposes only. The results from this case study may not be predictive for all

patients. Individual results may vary depending on a variety of patient specific

attributes.

The physician has been compensated by Bard Peripheral Vascular.

This product is not available for sale in the US

BPV/STN3/0116/0004

The Ideal Venous Stent

• Dedicated venous stent

design

• Easy and accurate

deployment

– Easy to deploy

– Radiopaque

– Limited foreshortening

• Large diameters

• Long lengths

• Balance between radial

force and flexibility

– High radial force

– High compression

resistance

– High flexibility

This product is not available for sale in the US

BPV/STN3/0116/0004

VENOVO™ Venous Stent Development

Innovation

Understanding Venous Disease

Development Testing Computational

Modeling

This product is not available for sale in the US

BPV/STN3/0116/0004

Venous Disease Understanding

• Collaborating with

physicians

• Ethnographic studies

• Human imaging studies

IVC

Iliac Vein

This product is not available for sale in the US

BPV/STN3/0116/0004

Development Testing

In-Vitro

Animal Durability

This product is not available for sale in the US

BPV/STN3/0116/0004

Radial Force and Crush Resistance

0,000

0,020

0,040

0,060

0,080

0,100

0,120

0,140

0,160

Bard Venovo14x160N=20

Optimed SinusVenous 14x80

N=3

Cook Zilver Vena14x100

N=2

Rad

ial R

es

isti

ve

Fo

rce

at

1m

m

ove

rsiz

e (

N/m

m)

Radial Resistive Force

0,00

0,50

1,00

1,50

2,00

2,50

3,00

Bard Venovo14x160N=20

Optimed SinusVenous 14x80

N=3

Cook Zilver Vena14x100

N=3L

oca

l C

om

pre

ss

ion

Fo

rce

(N

)

Crush Resistance

Bench testing may not be indicative of clinical performance. Different test methods may yield different results.

Competitive testing samples represent commercially available venous stents with CE mark as of June 2014.

This product is not available for sale in the US

BPV/STN3/0116/0004

Stent Flexibility

Bard

Cook Optimed

0

0,2

0,4

0,6

0,8

1

1,2

1,4

Bard Venovo 14x160 Optimed SinusVenous 14x80

Cook Zilver Vena14x100

3 P

oin

t B

en

din

g S

tiff

ne

ss

(N

)

Bench testing may not be

indicative of clinical performance.

Different test methods may yield

different results. Competitive

testing samples represent

commercially available venous

stents with CE mark as of June

2014.

Bard N=20

Optimed Sinus Venous N=3

Cook Zilver Vena N=3

This product is not available for sale in the US

BPV/STN3/0116/0004

Visibility

Images presented above are from a Bard GLP animal study in an ovine model.

Ovine Model, AP View

Compressed stent prior to

deployment

Ovine Model, AP View

During stent deployment

Ovine Model, AP View

Post stent deployment

This product is not available for sale in the US

BPV/STN3/0116/0004

VENOVO™ Venous Stent

• Tri-axial

• .035” OTW

• Dual-speed

thumbwheel

• Self-expanding nitinol

• 6 markers at ends (3

tantalum,

3 nitinol)

This product is not available for sale in

the US

BPV/STN3/0116/0004

VENOVO™ Venous Stent

Stent Diameters

10 mm 12 mm 14 mm 16 mm 18 mm 20 mm

Ste

nt

Length

s

20 mm

8F 9F 10F

40 mm

60 mm

80 mm

100 mm

120 mm

140 mm

160 mm

This product is not available for sale in the US

BPV/STN3/0116/0004

Post-thrombotic obstruction (PTS)

The opinions and clinical experiences presented herein are for informational purposes only. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes.

This product is not available for sale in the US

BPV/STN3/0116/0004

Stenting for PTS

The opinions and clinical experiences presented herein are for informational purposes only. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes.

This product is not available for sale in the US

BPV/STN3/0116/0004

Stenting for May-Thurner

The opinions and clinical experiences presented herein are for informational purposes only. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes.

This product is not available for sale in the US

BPV/STN3/0116/0004

Indication for Use

The VENOVO™ Venous Stent System is indicated for the treatment of stenoses and occlusions in the iliac and

femoral veins.

Contraindications

The Venovo™ Venous Stent System is contraindicated for use in:

• Patients with a known hypersensitivity to nitinol (nickel-titanium), and tantalum.

• Patients who cannot receive recommended antiplatelet and/or anti-coagulation therapy.

• Patients who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or

proper placement of the stent or the stent delivery system.

Please consult package insert for more detailed safety information and instructions for use.

Bard and Venovo are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are

property of their respective owners. Copyright © 2015, C. R. Bard, Inc. All Rights Reserved.

Illustrations by Mike Austin. Copyright © 2016. All Rights Reserved.

Not for sale or distribution in the U.S.